United States Physicians' Knowledge, Attitudes, and Practices Regarding Meningococcal Vaccination for Healthy Adolescents and Young Adults.

PURPOSE: The United States Advisory Committee on Immunization Practices (ACIP) recommends vaccination against meningococcal serogroups A, C, W, and Y (MenACWY) for all 11-12-year-olds, with a booster dose for 16-year-olds, and against meningococcal serogroup B (MenB) for 16-23-year-olds under shared clinical decision-making (SCDM). However, uptake of the MenB vaccine and the MenACWY booster dose is low. This study investigated United States physicians' knowledge, attitudes, and practices regarding recommending MenB and MenACWY vaccines to non-high-risk older adolescents and young adults. METHODS: An online survey was conducted in April-May 2022 among pediatricians, family physicians (FPs), general practitioners (GPs), and internists who had recommended the MenB and/or the MenACWY vaccine(s) to at least one 16-23-year-old in the past year. RESULTS: Among 407 participants, 50% correctly identified MenB as the leading cause of meningococcal disease among adolescents and young adults. Furthermore, 46% of physicians (47% of pediatricians, 40% of FPs and GPs, 53% of internists) answered correctly that MenB vaccination is recommended under SCDM, and 82% of physicians (96% of pediatricians, 70% of FPs and GPs, 65% of internists) answered correctly that MenACWY vaccination is routinely recommended. Among MenB-vaccinators, 78% reported having received some training or other information on implementing SCDM, and 65% rated recommending MenB vaccination as very important. DISCUSSION: Knowledge gaps, which varied by specialty, were identified regarding meningococcal disease and vaccine recommendations, particularly regarding MenB. Targeted education of physicians may facilitate discussions about MenB vaccination.

Treatment patterns for patients with advanced/metastatic cancers by site of care.

OBJECTIVES: To compare treatments, overall survival (OS), and total costs among patients receiving anticancer therapy in hospital outpatient vs physician office settings. STUDY DESIGN: This retrospective observational study utilized claims data from a large national health plan to identify patients with advanced/metastatic non-small cell lung cancer (aNSCLC), metastatic colorectal cancer (mCRC), or metastatic breast cancer (mBC) treated in hospital outpatient or physician office settings. METHODS: Patients enrolled in Medicare Advantage Prescription Drug or commercial plans for at least 180 days prior to and at least 30 days after start of first-line (1L) therapy were included. Treatments by lines of therapy, OS, and total costs were evaluated by site of care. RESULTS: Eligible patients included 4618 with aNSCLC, 2304 with mCRC, and 1411 with mBC. There were no major differences in 1L, second-line, or third-line therapy by site of care. Patients with aNSCLC in physician office had longer 1L duration (hospital outpatient, 96 days vs physician office, 102 days; P < .01), but there were no differences in duration of therapy by site of care for mBC or mCRC. Costs were higher in the hospital outpatient setting for mCRC and mBC, but there were no differences in OS for any of the cancers. CONCLUSIONS: Although patients received similar care in hospital outpatient and physician office settings, the differences in duration of treatment and costs warrant further evaluation.

Comparing Medical Utilization and Cost Outcomes in Oral Versus Injectable Immunotherapy Users with Chronic Inflammatory Joint and Skin Diseases.

BACKGROUND: Rheumatoid arthritis (RA), psoriatic arthritis (PsA), and psoriasis (PSO) are immune-mediated systemic, chronic inflammatory conditions. Moderate to severe disease is treated with conventional disease-modifying antirheumatic drugs (DMARDs) such as methotrexate, sulfasalazine, or leflunomide. If a patient does not respond to these firstline treatments, then tumor necrosis factor inhibitor (TNFi) or non-TNFi immunotherapy agents are administered via infusion, injection, or taken orally. Although the effectiveness of established infusion, injection, and newer oral therapies are known, the relative effectiveness among the routes of administration is not well understood. OBJECTIVE: To compare drug use, health care resource utilization, and costs among patients who are treatment-naive to oral immunotherapy and injectable biologic immunotherapy. METHODS: This retrospective observational study used claims data from a large U.S. health plan to identify new users of oral and injectable immunotherapy, diagnosed with a joint (RA or PsA), skin (PSO), or joint and skin condition from July 1, 2014, to June 30, 2017. The index date was the first claim for an oral or injectable medication. Medicaid, Medicare Advantage, and commercial plan patients aged 19-89 years with continuous enrollment 6 months before and 12 months after the index date were included in the study. Outcomes were adjusted using propensity score by inverse probability of treatment weighting. Treatment discontinuation, switching, health care resource utilization, and costs were measured during the post-index period. RESULTS: Oral versus injectable users with joint (n = 458 vs. 3,875), skin (n = 265 vs. 951), or joint and skin (n = 171 vs. 805) conditions were identified. For drug utilization outcomes, no differences in discontinuation rates were observed between oral and injectable groups for any of the cohorts. However, those in skin and joint and skin cohorts had higher rates of switching to other immunotherapies in patients initiated on orals compared with injectables. Health care resource utilization outcomes were mixed. While mean outpatient and physician office visits were significantly higher in oral compared with injectable groups across all 3 cohorts, no differences were observed for inpatient stays. Total costs (medical plus pharmacy) were lower for oral groups across all 3 cohorts. Pharmacy costs were lower for oral groups, but medical costs were higher for oral groups across all 3 cohorts. CONCLUSIONS: This is the first population-level study at a route-of-administration level, which compared switching, health care resource utilization, and costs across several conditions. Switching drugs was more likely in the oral group, which may indicate lower effectiveness or tolerability of oral immunotherapies relative to injectables. Health care resource utilization was higher in the oral group, but total costs were lower, which was likely driven by the lower costs of oral drugs. DISCLOSURES: This study was a Humana internal study, and all authors were at the time employees of Humana and used Humana resources. The authors have no conflicts of interest or financial interests to disclose that relate to the research described in this study. This study was presented as a podium and poster presentation at the AMCP Managed Care & Specialty Pharmacy Annual Meeting; April 23-26, 2018; Boston, MA.

Healthcare utilization and costs with fixed-source versus variable-source tacrolimus in patients receiving a kidney transplant.

AIMS: Switching drug manufacturers in transplant patients may require an increased intensity of therapeutic monitoring, leading to additional healthcare visits, associated laboratory tests, and perhaps hospitalizations. As real-world studies examining the interchangeability of tacrolimus from different manufacturers are limited, the purpose of this study was to examine the healthcare resource utilization (HRU) and economic impact of tacrolimus-switching in kidney transplantation. MATERIALS AND METHODS: This cross-sectional, retrospective study examined HRU and healthcare costs (HCCs) among patients with a kidney transplant who were prescribed tacrolimus from fixed-source (FS) vs variable-source (VS) manufacturers using claims data from the large US health plan Humana from October 1, 2012, to December 31, 2013. RESULTS: Overall, 1,024 patients were identified (FS: n = 674, 66%; VS: n = 350, 34%). The number of therapeutic drug monitoring (TDM) events for the VS group was 13% greater than for the FS group after controlling for demographics, comorbidity score, and number of medications (incidence rate ratio = 1.13, p = .033). Adjusted total HCCs were 9% lower for VS (US$28,054 vs US$30,823, p = .045). In the unadjusted analysis, VS had greater emergency department (ED) utilization (45% vs 35%, p < .002). In the VS group, the mean (standard deviation [SD]) number of days from manufacturer switch to first outpatient visit was 23.8 (33.6), and the number of days (SD) to first TDM event was 43.6 (56.2). LIMITATIONS: Study limitations include the lack of availability of many transplant-specific variables within the Humana database, potential errors/omissions in claims coding, and restriction of cross-sectional data examination to a 1-year period. CONCLUSIONS: VS patients had greater TDM and lower total HCCs. Further research is warranted to understand the drivers of ED use among the VS group, and to determine factors associated with delayed TDM after regimen modification. Opportunities may exist to improve the quality of care for patients receiving immunosuppressant treatment with tacrolimus.

The Effect of an Educational Intervention on Adherence to Intraocular Pressure-Lowering Medications in a Large Cohort of Older Adults with Glaucoma.

BACKGROUND: Glaucoma is a progressive, irreversible disease that can lead to vision loss and lower quality of life if treatment is not optimized. Effective glaucoma therapies are available to lower intraocular pressure (IOP) and minimize or delay disease progression. Nonetheless, adherence to treatment remains suboptimal for many patients. OBJECTIVE: To identify potentially nonadherent patients and evaluate the effect of patient- and physician-centric educational interventions on adherence by using a validated predictive model of nonadherence to glaucoma medication. METHODS: This prospective, randomized, controlled, and interventional study included Humana Medicare Advantage Prescription Drug plan patients with a glaucoma diagnosis between May and October 2014, ≥ 1 pharmacy claim for glaucoma medication, and ≥ 50% likelihood of nonadherence. Patients and physicians were randomized to cohorts A (no interventions), B (physician intervention), or C (patient and physician interventions). Physicians in cohorts B and C received information on the model, adherence, and patient profiles at baseline and months 3, 6, and 9. Patients in cohort C received educational materials on glaucoma and adherence (same schedule). The primary outcome was the proportion of days covered (PDC) with medication over 12 months. Adherence was defined as PDC ≥ 0.80. RESULTS: Overall, 23,306 patients and 2,955 physicians were eligible. After excluding physicians with < 3 nonadherent patients, each cohort included 200 physicians and 600 patients. Mean PDC was 0.54-0.56 across cohorts. At 12 months, ≥ 90.5% of physicians and ≥ 75.5% of patients remained in the study; mean PDC was 0.53-0.54 across cohorts. No statistically significant between-cohort differences in PDC and adherence were observed. CONCLUSIONS: Intensive educational mailings to patients and their physicians did not improve PDC or adherence in this large population of potentially nonadherent patients with glaucoma. Findings highlight the difficulty of improving adherence in a disease that requires lifelong therapy despite being largely asymptomatic and can inform development of future interventions aimed at improving adherence to glaucoma therapy. DISCLOSURES: This study was sponsored by Allergan plc (Dublin, Ireland). Fiscella and Chandwani are employees of Allergan plc. Caplan, Kamble, Bunniran, and Uribe are employees of Comprehensive Health Insights, a Humana company. The authors did not receive honoraria or other payments for authorship.

A prospective study of elderly initiating mirabegron versus antimuscarinics: Patient reported outcomes from the Overactive Bladder Satisfaction Scales and other instruments.

AIMS: To understand differences in patient reported outcomes (PRO) between patients initiating mirabegron or an antimuscarinic using a validated PRO instrument, OAB-Satisfaction (OAB-S). METHODS: This prospective observational study used real-time prescription claims from Humana to identify Medicare patients initiating mirabegron or an antimuscarinic to participate in a series of three phone surveys over ninety days. RESULTS: A total of 1897 mirabegron and 2444 randomly selected antimuscarinic initiators were identified; 174 mirabegron and 193 antimuscarinic initiators completed all three surveys. Among responders, mirabegron initiators were slightly older (76 vs 75 years, P = 0.032), included more males (32% vs 23%, P = 0.044), more likely to have prior OAB treatment (21% vs 13%, P = 0.048), and had greater medication burden (number of unique medications: 10.0 vs 8.7, P = 0.014). There were no between-group differences at any time or on any OAB-S scale. There were significant within-group differences at follow-up compared to baseline for OAB-S scales: "impact on daily living," with improvement over the 90-day survey period for both mirabegron (P = 0.008) and antimuscarinic (P < 0.001); "interruption of day-to-day life," with improvement for both mirabegron (P < 0.001) and antimuscarinic (P < 0.001); and improvement in "OAB control" for mirabegron (P < 0.001) and antimuscarinic (P < 0.001). CONCLUSIONS: Mirabegron initiators tended to be older, had a greater number of unique medications and previously tried prescriptions to treat OAB; nonetheless, mirabegron, and antimuscarinic initiators reported similar trends in improvement in PROs over the first 90 days of treatment. Significant improvement in daily impact of OAB was observed after treatment initiation; however, no significant differences between groups were observed.

Predictors of Nonadherence to Topical Intraocular Pressure Reduction Medications Among Medicare Members: A Claims-Based Retrospective Cohort Study.

BACKGROUND: Reported adherence rates with ocular hypotensive medications typically range from 51% to 56% over the first year of therapy. As intraocular pressure (IOP) reduction slows the progression of vision loss from glaucoma, early identification of nonadherent members is crucial to effective disease management. OBJECTIVES: To (a) identify member characteristics and other factors related to nonadherence with topical IOP-lowering medications available in administrative claims data and (b) create a predictive model incorporating these variables. METHODS: This retrospective cohort study analyzed data from Humana's administrative claims database. The study cohort included members aged 65-89 years enrolled in a Medicare Advantage Prescription Drug plan (MAPD; medical and pharmacy benefits), with > 1 topical IOP-lowering medication claims between January 2011 and September 2012 and a minimum of 24 months of continuous enrollment-12 months before and 12 months after the initial (index) prescription claim for a topical IOP-lowering medication. Adherence was defined as the proportion of days covered (PDC) with drug supply (calculated from the number of drops per bottle and dose) over the first year after the index prescription. Members with PDC > 0.80 were considered adherent, while members with PDC < 0.80 were considered nonadherent. Multivariable stepwise logistic regression with backward elimination was used to construct a predictive model for the likelihood of nonadherence (PDC < 0.80). The model was developed using 28 input variables*#x2013;10 variables were retained in the final model. RESULTS: 73,256 MAPD members were included in this study; most (69%) of these members were continuing topical IOP-lowering medication users. The proportion of patients adherent (PDC > 0.80) to IOP-lowering medications was 51%. The study sample was split, using a 2:1 ratio, into a development sample (n = 48,840 members) and a validation sample (n=24,416 members). The model performed equally well in the development sample and the validation sample (area under the curve = 0.71 for development and validation sets), making it appear robust in this Medicare population. In the final predictive model, characteristics increasing the likelihood (P < 0.01) of nonadherence to IOP-lowering medication within the MAPD population included index IOP prescription filled through mail order, higher medical costs during the pre-index period, being a new IOP-lowering medication user, and being male. Characteristics that lowered the likelihood of nonadherence included advanced age, higher pharmacy costs during the pre-index period, receiving a low-income subsidy, residing in the South, and a previous diagnosis of open-angle glaucoma or history of glaucoma surgery. CONCLUSIONS: Nonadherence to topical IOP-lowering medication can be predicted with 10 commonly available demographic, clinical, and treatment-related variables generally available in administrative claims data for an MAPD population. Given that this predictive model was constructed using these generally available data, it could potentially be replicated by other health plans for use in predicting nonadherence to topical IOP-lowering medications among MAPD plan members. This predictive model can be used to identify members that are likely to be nonadherent in order to target interventions intended to improve ocular hypotensive medication adherence. DISCLOSURES: Funding for this study was contributed by Allergan. Comprehensive Health Insights was contracted by Allergan to conduct this study. Sheer, Bunniran, and Uribe are employed by Comprehensive Health Insights/Humana and own stock in Humana. Fiscella, Chandwani, and Patel are employed by Allergan. Study concept and design were contributed by Sheer, Fiscella, and Patel, along with Bunniran and Uribe. Sheer and Bunniran took the lead in data collection, and data interpretation was performed by Bunniran and Uribe, along with the other authors. The manuscript was written and revised by Sheer, Bunniran, Chandwani, and Uribe, with assistance from Fiscella and Patel.

Pharmaceutical product withdrawal: attributions of blame and its impact on trust.

BACKGROUND: Six major pharmaceutical products were withdrawn from the market from 2000 to 2006. Little evidence exists in understanding consumer reactions to such events and the influence the withdrawal has on its competitors. OBJECTIVE: To explore consumers' attribution of blame after pharmaceutical product market withdrawal (PPMW) and its effect on trust. METHODS: Subjects were assigned randomly to 4 groups and provided a unique hypothetical PPMW scenario and asked to imagine themselves in the situation described. Each scenario represented a different "distance" from the PPMW (eg, whether subjects were asked to assume they were taking the withdrawn drug or a therapeutic substitute). Blame of and trust in several key professionals/groups were measured. RESULTS: Closer "distance" to the PPMW resulted in higher blame attributions for the Food and Drug Administration (FDA), pharmaceutical company (Pharma), and the physician. Although the pattern of trust scores did not differ based on "distance," insurance companies and Pharma suffered from low trust, whereas pharmacists and physicians received higher trust ratings. Blaming appeared to be no different between consumers on a withdrawn product and those consumers on a product in the same therapeutic class ("substitute" product). CONCLUSION: Substitute products (drugs in the same therapeutic class) appear to be affected in the event of a PPMW, although drugs used to treat the same disease do not appear to be so affected. The difficult-to-explain findings with respect to trust may be accounted for by the fact that trust is more downstream than blame (based on the scenario presentations) and that trust is a complex construct with multiple antecedents. Although the bonds of interpersonal trust remain stronger than those of institutional trust, the likelihood of situational trust versus overall trust may complicate this picture of understanding trust. It may be possible that trust is impervious to this one negative instance versus many positive interactions.

Ratings of journals for the dissemination of pharmacy-related social and administrative science.

BACKGROUND: It has been over a decade since a journal quality rating study has been conducted in the social and administrative sciences (SAdS). This study sought to reevaluate perceptions of journal quality. OBJECTIVES: To develop a list of journals that are suitable publication venues for SAdS scholars and compare the quality of these journals as rated by school of pharmacy deans, SAdS department/division chairs, and SAdS faculty. METHODS: A list of journals was assembled and presented to a Delphi panel of 15 SAdS scholars. Using a modified Delphi technique, the panel refined the list by judging the suitability of each journal as a publication venue for scholars. This list was used in a survey administered via the Internet. Journal quality was rated on a 7-point Likert-type scale with the option of indicating unfamiliarity with each journal. Differences in quality ratings between faculty, chairs, and deans were explored. Adjusted rating scores were calculated based on familiarity with journals. Ratings from the current study were compared to previous studies. RESULTS: One hundred and twelve journals emerged from the modified Delphi technique. Kruskal-Wallis analysis of variance found no significant difference in perceived journal quality across all journals evaluated by the 3 groups (KW=3.91). Groups did differ in their familiarity (KW=11.71, P<.01), with faculty being the most familiar with the journals and deans being the least familiar. Journal rankings were highly correlated with journal rankings from previously published studies. CONCLUSIONS: Results of this study have implications for scholars choosing publication venues and those who make decisions contingent on scholars' publication records. These differences may represent a positive or negative bias that affects hiring as well as tenure and promotion decisions. This study provides guidance for decisions reliant on publication records, but should not be used exclusively as such an indicator.